On May 14, 2019 Medigene AG (FSE: MDG1, Frankfurt, Prime Standard), a clinical stage immuno-oncology company focusing on the development of T cell immunotherapies, reported financial results for the first three months of 2019 and provided a review of recent accomplishments and anticipated upcoming milestones (Press release, MediGene, MAY 14, 2019, View Source [SID1234536275]). The company further adjusted its financial guidance for the fiscal year 2019 following two business transactions announced in the second quarter of 2019.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Major events since the beginning of 2019:
* Medigene treated the first patient in the Phase I/II clinical trial of the T cell receptor-modified T cell immunotherapy (TCR-T) MDG1011
* Medigene and Roivant affiliate Cytovant entered into a strategic partnership for the research and development of cell therapies in Asia
* bluebird bio presented preclinical data of first TCR candidate from ongoing collaboration with Medigene and announced plans to start clinical development of this MAGE-A4 targeting TCR in 2020
* Medigene licensed a chimeric co-stimulatory receptor to enhance TCR therapies for solid tumors
* Medigene sold the remaining rights and stocks of the legacy product Veregen
* Medigene presented positive results from in vitro tests to assess the potential TCR-mediated off-target toxicity for neuronal cells at the annual meeting of the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) and presented preclinical data on the selective killing of tumor cells by PRAME TCR-transduced T cells at the AACR (Free AACR Whitepaper) conference
* Medigene obtained two European patents for its dendritic cell (DC) vaccine platform and for the TCR building block library to develop neoantigen-specific TCRs
* Medigene appointed Axel-Sven Malkomes as CFO/CBDO

Prof. Dolores Schendel, CEO of Medigene AG, comments: "We have had a very productive start to 2019 with progress in our own clinical projects and in the development of partner programs. Patient treatment in our TCR-T study MDG1011 has started, and we anticipate accelerating patient recruitment following the upcoming expansion of the number of clinical centers in this trial. Additionally, our licensing agreement with Roivant/Cytovant will enable us to generate and deliver our TCR constructs and Dendritic Cell vaccine to Cytovant, who will ultimately develop, manufacture and commercialize these promising immunotherapies for the East Asian patient populations."
"Moreover, we were thrilled that the first TCR discovery project we developed for our partner bluebird bio yielded a TCR candidate displaying convincing preclinical data and has been selected for clinical development by bluebird bio."
"Finally, with the sale of the remaining Veregen rights, we have completed our transformation into a pure-play immuno-oncology company. With an improved financial forecast and sufficient liquid assets, we are well positioned to continue making further progress across our immunotherapy platform and development candidates."

Three months’ financial results:
* Revenue from immunotherapies stable at EUR 1.4 m
* Research and development expenses (R&D) increased as planned by 28% to EUR 5.5 m due to expansion of clinical activities
* EBITDA loss increased as planned by 31% to EUR 5.0 m due to progress in immunotherapy programs
* Net loss for the period increased as planned by 36% to EUR 5.7 m
* Cash and cash equivalents and time deposits of EUR 65.5 m as at March 31, 2019

Financial guidance 2019:

Medigene revises the financial guidance for 2019 published in the 2018 Annual Report following the Roivant/Cytovant partnership in cellular immunotherapies and the sale of remaining rights to Veregen, both closed in April 2019.
* The Company improves its revenue guidance and expects to generate total revenues of between EUR 10 – 11 m (previous guidance: EUR 5.5 – 6.5 m) in 2019, approximately EUR 5 m anticipated from the cell therapy deal with Roivant/Cytovant.
* Medigene continues to expect research and development expenses of EUR 24 -29 m in 2019 due to progress of the preclinical and clinical development programs including manufacturing costs for clinical trial material.
* The Company also confirms its EBITDA-guidance and continues to expect a loss at EBITDA level of EUR 23 – 28 m, as the additional revenue from the Roivant/Cytovant deal will be compensated by a non-cash effect of EUR -4 and -5 m resulting from the Veregen deal, as announced in the press release from April 8, 2019.

Outlook immunotherapies:
Medigene confirms its outlook for immunotherapies published in the Annual Report 2018:

T cell receptor-modified T cells (TCR-Ts)

Current Phase I/II clinical trial with MDG1011: In addition to the three active study centers to date, it is anticipated that up to five new centers will begin recruiting patients in the second quarter and early third quarter of 2019. The University Clinic of Dresden was the first new study center to open. In 2019, the focus of the trial will be the recruitment of the first dose cohorts to assess the safety and tolerability of the treatment with MDG1011.

Development of additional TCR candidates: In 2019, in addition to the MDG1011 clinical trial, Medigene will work on characterizing new TCR candidates for future clinical trials under the responsibility and funding of Medigene and collecting preclinical data to prepare further clinical TCR trials.

Evaluation of HA-1 TCR as a potential clinical candidate: Medigene is assessing the in-licensed HA-1-specific T cell receptor to determine if it is a suitable candidate for expansion of Medigene’s TCR-T clinical development program.

Optimization of future TCR therapies for solid tumors: In addition, the chimeric co-stimulatory receptor (the PD-1/4-1BB molecule) exclusively licensed from HMGU will be assessed in combination with Medigene’s tumor-specific T cells (TCR-Ts) in preclinical models in order to optimize future TCR therapies for solid tumors.

TCR partnerships: Within the framework of the collaboration entered into with Roivant/Cytovant, Medigene will now, together with the collaboration partner, undertake preparations to generate TCR constructs tailored specifically to Asian patients using its proprietary TCR discovery platform. In addition, Medigene continues the successful collaboration with bluebird bio.

IIT from academic partners: In addition to the Company’s own development activities, the start of the academic investigator initiated TCR-modified T cell therapy clinical trial (IIT) under the responsibility of Max-Delbrück-Center and Charité University Hospital in Berlin, Germany is expected.

Dendritic cell vaccines (DCs)

Conclusion of the Phase I/II clinical trial at the end of 2019: Medigene will continue the current Phase I/II clinical trial for DC vaccines for the treatment of acute myeloid leukemia (AML) as planned and bring it to a conclusion at the end of 2019. The data from the interim analysis will be presented beforehand at the Annual Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) taking place from June 13 – 16 in Amsterdam. The final data will be available towards the end of 2019/beginning of 2020.

The full version of the quarterly statement 3M-2019 can be downloaded here: View Source

Conference call and webcast: A telephone conference (webcast) in English will be held today at 3:00 pm CET (Munich/Frankfurt) / 9:00 am EST (New York) and transmitted live via webcast. Access and transmission of the synchronized presentation slides and a recording of the presentation is available on the homepage of Medigene at View Sourcewebcasts/

On May 14, 2019 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage immunotherapeutics company, reported financial results for the first quarter ended March 31, 2019 and provided a business update (Press release, Altimmune, MAY 14, 2019, View Source [SID1234536296]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We made great progress in the first quarter, as we executed on our strategy and worked to build long-term shareholder value," said Vipin K. Garg, Ph.D., President and Chief Executive Officer. "We are diligently exploring opportunities to expand our pipeline via acquisition and in-licensing opportunities in both immuno-oncology and liver disease indications. We continue to advance the development of our current key assets, HepTCell and ALT-702, and anticipate achieving significant milestones in both these programs during the next 12 to 18 months. In addition, we have made important advances in both our NasoVAX and NasoShield programs."

Recent Highlights

HepTcell Phase 1 Clinical Trial Data Presented at International Liver Congress
The Company presented results of its HepTcell Phase 1 clinical trial at The International Liver CongressTM sponsored by The European Association for the Study of the Liver (EASL). Mark Thursz, MBBS, MD, FRCP, Professor of Hepatology at Imperial College, London, presented HepTcell Phase 1 data in the session entitled "Hepatitis B – Drug Development." As previously announced, the successful clinical trial met its primary endpoint of safety and showed that HepTcell treatment was associated with increased HBV-specific cellular immune responses. The Company is preparing to initiate a Phase 2 clinical study in the U.S. in 2020.

ALT-702 Preclinical Development Initiated
Recently initiated preclinical development of its immunostimulant product candidate, ALT-702. ALT-702 is based on a new synthetic peptide conjugate technology platform that allows localized immune stimulation without the safety risk of systemic inflammation. ALT-702 represents a new approach in immuno-oncology that can act alone or improve the effectiveness of immune checkpoint inhibitors, oncolytic viruses and other approaches in immuno-oncology. The Company expects to provide an update on the progress of ALT-702 later this year.

NasoVAX Phase 2 Extension Study Completed Showing Durable Immune Response
The Company presented results of its NasoVAX Phase 2 study and the recently completed extension study at the World Vaccine Congress. As previously announced, the Phase 2 data showed that NasoVAX was well-tolerated and highly immunogenic, demonstrating 100% seroprotection at two of the three dose levels studied. Data from the extension study showed that the immunogenic responses were durable with 100% of the evaluated subjects remaining seroprotected with no decrease in seroconversion rate more than one year after vaccination. Durable responses on the order of one year are not expected from current injected influenza vaccines and suggest that the immune response induced by NasoVAX could be protective for the duration of a long flu season. The Company is actively looking for a strategic partner to further develop and commercialize NasoVAX.

NasoShield Investigation Completed with Potential Path Forward in the Clinic
Completed the investigations of potential causes that may have contributed to the lower than expected immune response in the Phase I study of NasoShield funded through a contract (HHSO100201600008C) with the Biomedical Advanced Research and Development Authority ("BARDA"). The results of these investigations are very encouraging and clearly show that while the vaccine product used in the clinical study continues to meet all manufacturing standards, the immune response to NasoShield is strongly affected by the intranasal administration method. Based on these findings, the Company believes that a simple adjustment to the intranasal dosing procedure may allow NasoShield to elicit a full immune response in humans.

Completed Registered Direct Offering Raising Gross Proceeds of $14 Million
Completed a Registered Direct Offering in March 2019 that raised gross proceeds of $14 million, which brings total gross proceeds received from equity offerings since September 2018 to $56 million. These financings provide the Company with the necessary resources to further develop its programs and position itself for potential acquisitions.

Financial Results for the First Quarter Ended March 31, 2019

The Company had cash, restricted cash and cash equivalents of $44.9 million at March 31, 2019. This was an increase of $10.6 million since the prior year end due to the receipt of net proceeds of $12.7 million through the Registered Direct Offering offset by operating cash burn of $2.1 million.

Revenue in the first quarter was $2.96 million compared to $2.69 million in the prior year period. The increase was due primarily to billings under the Company’s NasoShield contract with BARDA.

Research and development expenses in the first quarter were $3.22 million compared to $5.75 million in the prior year period. The decrease was primarily attributable to lower spending on its NasoVAX and HepTcell programs.

General and administrative expenses in the first quarter were $2.07 million compared to $2.45 million in the prior year period. The decrease was due primarily to a reduction in legal and professional costs.

Net loss attributed to common stockholders for the first quarter was $2.55 million, or ($0.27) per share, compared to $5.06 million, or ($7.49) per share in the same period of 2018.

Conference Call Details

Date:

Wednesday, May 15, 2019

Time:

8:30am Eastern Time

Domestic:

877-423-9813

International:

201-689-8573

Conference ID:

13690295

Webcast:
View Source

On May 14, 2019 OncoCyte Corporation (NYSE American: OCX), a developer of novel, non-invasive tests for the early detection of lung cancer, reported financial and operating results for the first quarter ended March 31, 2019 and provided a corporate update (Press release, BioTime, MAY 14, 2019, View Source;p=RssLanding&cat=news&id=2398606 [SID1234536260]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"During the first quarter and now into the second quarter, we continued to make great strides advancing DetermaVu through clinical development," commented William Annett, President and Chief Executive Officer of OncoCyte. "In addition to the previously-reported positive results of our R&D Validation study, we recently announced positive results from our Analytical Validation study of DetermaVu. We have moved quickly into the next phase and expect to complete CLIA Laboratory Validation soon. We will then proceed to the final study before commercialization, an approximately 440 patient blinded prospective Clinical Validation study."

"With each successful validation step, we are rapidly approaching commercial availability, which we anticipate in the second half of this year. In parallel, we have begun to develop plans to explore the utility of DetermaVu in other solid tumor cancer indications with the goal of making this novel technology available to as many patients as possible. We continue to believe that DetermaVu, which leverages our proprietary Immune System Interrogation approach to detect subtle changes in immune biomarkers in response to early-stage cancer, is poised to change the paradigm in lung cancer diagnostics. We look forward to efficiently completing the remaining development steps and transitioning to a commercial-stage company."

Highlights

Successfully completed Analytical Validation and initiated CLIA Laboratory Validation study

Announced a late-breaking abstract and discussion session at the American Thoracic Society 2019 International Conference detailing the compelling results from the R&D Validation study, a blinded, prospective study demonstrating best-in-class performance with sensitivity of 90% and specificity of 75%

Completed a successful equity raise of $37.3 million in net proceeds which provides the funding to complete the development of DetermaVu and initiate commercialization efforts.

On-track to complete remaining validation studies by mid-year and make DetermaVu commercially available in the second half of 2019

Remaining Validation Pathway for DetermaVu:

2Q 2019: CLIA Laboratory Validation study – Currently underway to rerun between 100 and 120 patient blood samples previously run in the R&D Validation study to confirm that the same positive results are obtained on the analytically validated systems in OncoCyte’s CLIA laboratory

Mid-year 2019: Clinical Validation study – Will run approximately 440 blinded, prospectively-collected blood samples to establish DetermaVu’s performance in an independent, blinded data set as a final confirmation of test sensitivity and specificity in OncoCyte’s CLIA lab setting

2H 2019: Anticipated commercial availability of DetermaVu

Post-launch (2020 initiation): Clinical Utility study – Will conduct a real world evidence study to demonstrate a net improvement in patient outcomes and cost savings for the healthcare system from the use of DetermaVu as a confirmatory diagnostic test for lung cancer

First Quarter 2019 Financial Highlights

At March 31, 2019, OncoCyte had cash, cash equivalents and marketable securities of $39.9 million as compared to $8.4 million at December 31, 2018. The balance sheet was strengthened in February 2019 with the successful equity raise of $37.3 million in net proceeds from an underwritten public offering.

For the first quarter ended March 31, 2019, OncoCyte incurred a net loss of $3.9 million, or $(0.08) per share, as compared to $3.8 million, or $(0.12) per share, for the three months ended March 31, 2018.

Operating expenses for the three months ended March 31, 2019 were $4.0 million, and $3.2 million on an as-adjusted basis, as compared to $3.9 million, or $3.4 million on an as adjusted basis, for the same period in 2018.

The reconciliation between GAAP and non-GAAP operating expenses is provided in the financial tables included with this earnings release.

Research and development expenses for the quarter ended March 31, 2019 were $1.3 million as compared to $1.5 for the same period in 2018, relatively unchanged quarter over quarter, as OncoCyte continued to focus resources on the development and commercialization of DetermaVu.

General and administrative expenses for the three months ended March 31, 2019 were $2.4 million, as compared to $1.7 million for the same period in 2018, an increase of $0.7 million. This increase is primarily attributable to $0.4 million in personnel and related expenses and $0.3 million in stock-based

compensation expense due to increased grants of equity awards.

Sales and marketing expenses for the three months ended March 31, 2019 were $0.2 million, as compared to $0.7 million for the same period in 2018, a decrease of $0.5 million, primarily attributable to a decrease in marketing personnel and consultants as OncoCyte concentrated its resources on the development of DetermaVu rather than on marketing related activities.

Conference Call

The Company will host a conference call today, May 14, 2019, at 4:30 pm EDT / 1:30 pm PDT to discuss the results along with recent corporate developments.

The dial-in number in the U.S./Canada is 877-407-9716; for international participants, the number is 201-493-6779. For all callers, please refer to Conference ID 13689785. To access the live webcast, go to the investor relations section on the Company’s website, View Source

About DetermaVu

DetermaVu is being developed as an intermediate step to confirm the absence of cancer between imaging modalities (LDCTs) detecting suspicious lung nodules and downstream invasive procedures that determine if the nodules are malignant. OncoCyte estimates that a $2 billion to $4.7 billion annual market could develop in the U.S. for its confirmatory lung cancer liquid biopsy test, depending on the scope of physician utilization, market penetration and reimbursable pricing.

DetermaVu has the potential to dramatically reduce U.S. healthcare costs by billions of dollars each year by eliminating unnecessary biopsies, which, according to a study of Medicare data by an independent health economics firm, cost on average $14,634 each. In addition, DetermaVu can provide great benefit to patients by avoiding invasive biopsies and the complications that arise in up to 24% of those procedures, and deaths that occur in up to 1% of cases.

DetermaVu is a trademark of OncoCyte Corporation.

On May 14, 2019 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq:SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported that Briggs W. Morrison, M.D., Chief Executive Officer of Syndax, will present at the UBS Global Healthcare Conference on Tuesday, May 21, 2019 at 10:30 a.m. ET at the Grand Hyatt New York (Press release, Syndax, MAY 14, 2019, View Source [SID1234536276]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live webcast of the Company’s presentation can be accessed from the Investor section of the Company’s website at www.syndax.com, where a replay of the events will also be available for a limited time.

On May 14, 2019 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported financial results and business highlights for the first quarter 2019 (Press release, Cyclacel, MAY 14, 2019, View Source [SID1234536297]). The Company’s net loss applicable to common shareholders for the three months ended March 31, 2019 was $1.9 million. As of March 31, 2019 cash and cash equivalents totaled $17.9 million.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We continue to execute on our strategy to develop innovative therapies to overcome cancer resistance mechanisms through combinations of our candidates with approved drugs," said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. "Two Phase 1, dose escalation studies evaluating CYC065 in combination with venetoclax in patients with relapsed/refractory CLL and CYC140 as single agent in a first-in-human trial are open for accrual and patients have been dosed on both studies. Two additional studies evaluating combinations of CYC065 and sapacitabine with venetoclax are under review by institutional review boards. The Phase 1 study of single agent CYC065 has been amended to evaluate an oral form of CYC065. We are pleased to report that the first two patients with BRCA mutant breast cancer treated in the IST evaluating sapacitabine and olaparib have achieved tumor shrinkage. During the quarter, we also extended our projected cash runway to the end of 2020 through our ATM equity sales agreement."

Key Company Highlights

·Data was presented at the 2019 AACR (Free AACR Whitepaper) Annual Meeting from the Company’s DNA damage response program with an oral, sequential regimen of sapacitabine and seliciclib from an expansion cohort in patients with BRCA mutant metastatic breast cancer. The data demonstrated that the regimen was safe and led to a clinical benefit rate of 30%. All eight PARP inhibitor naïve patients, half of the patients previously treated with platinum agents and one on previous PARP inhibitor responded. Progression on previous platinum or PARP inhibitors was associated with lack of benefit. Both sapacitabine and PARP inhibitors are more effective in cancer cells with BRCA mutations or other homologous recombination repair deficiencies.
·Based on data from the above study, the investigators are enrolling a Phase 1b/2 study with an oral, concomitant regimen of sapacitabine and olaparib in patients with BRCA mutant breast cancer. According to the investigators three patients have been dosed. The first two achieved tumor shrinkage and continue on treatment and the third has completed first cycle without dose-limiting toxicity. Dual targeting of the DNA damage response pathway with sapacitabine and olaparib may improve the current standard of care for such patients.
·Two patients have been treated in the Phase 1, dose escalation clinical trial evaluating CYC065 in combination with venetoclax, a Bcl-2 inhibitor, in patients with relapsed/refractory CLL. Preclinical data presented at the 2018 AACR (Free AACR Whitepaper) showed synergistic activity of CYC065 and venetoclax combination in CLL tumor samples, including those with 17p deletions. The combination was also active in CLL samples resistant to either agent alone, suggesting that dual targeting of Mcl-1 and Bcl-2 dependent mechanisms could overcome intrinsic resistance to each individual compound.
·Two patients have been dosed in the recently opened Phase 1, first-in-human, dose escalation study evaluating CYC140 monotherapy in patients with advanced leukemias. CYC140 is a small molecule, selective polo-like-kinase 1 (PLK1) inhibitor that has demonstrated potent and selective target inhibition and high activity in xenograft models of human cancers.
·The Company raised net proceeds of approximately $4.1 million from its Common Stock Sales Agreement with H.C. Wainwright.

x 200 Connell Drive, Suite 1500, Berkeley Heights, NJ 07922, USA Tel +1 908 517 7330 Fax +1 866 271 3466

¨ 1 James Lindsay Place, Dundee, DD1 5JJ, UK Tel +44 1382 206 062 Fax +44 1382 206 067

www.cyclacel.com – [email protected]

Key Upcoming Business Objectives

· Initiate CYC065-venetoclax Phase 1 study in patients with relapsed or refractory AML or MDS;
· Initiate sapacitabine-venetoclax Phase 1 study in patients with relapsed or refractory AML or MDS;
· Report initial data from the CYC065-venetoclax Phase 1 study in relapsed/refractory leukemias;
· Report initial data from the CYC140 Phase 1 First-in-Human study;
· Report initial data and bioavailability from the Phase 1 study of an oral formulation of CYC065;
· Report updated CYC065 Phase 1 data in patients with advanced solid cancers;
· Report data from the IST Phase 1b/2 trial of sapacitabine-olaparib combination in patients with BRCA mutant metastatic breast cancer when reported by the investigators;
· Determine regulatory pathway and submissibility of sapacitabine in elderly AML patients.

Financial Highlights

As of March 31, 2019, cash and cash equivalents totaled $17.9 million compared to $17.5 million as of December 31, 2018. The increase of $0.4 million in the three months was primarily due to net proceeds from a Common Stock Sales Agreement with H.C. Wainwright of $4.1m, offset by net cash used in operating activities of $3.7 million. The Sales Agreement was concluded in the first quarter 2019.

Research and development expenses were $1.0 million for the three months ended March 31, 2019 compared to $0.8 million for the same period in 2018.

General and administrative expenses were $1.2 million for the three months ended March 31, 2019 compared to $1.4 million for the same period in 2018.

Other income, net for the three months ended March 31, 2019 was $0.1 million compared to $0.6 million for the same period of the previous year.

The United Kingdom R&D and tax credit was $0.3 million for the three months ended March 31, 2019 compared to $0.2 million for the same period in 2018.

Net loss for the three months ended March 31, 2019 was $1.8 million compared to $1.3 million for the same period in 2018. With the projected cash-sparing benefits accruing from the MD Anderson alliance the Company believes that cash and marketable securities, which were approximately $17.9 million as of March 31, 2019, will be sufficient to finance operations through the end of 2020.

Conference call information:

US/Canada call: (877) 493-9121 / international call: (973) 582-2750

US/Canada archive: (800) 585-8367 / international archive: (404) 537-3406

Code for live and archived conference call is 9383419

For the live and archived webcast, please visit the Corporate Presentations page on the Cyclacel website at www.cyclacel.com. The webcast will be archived for 90 days and the audio replay for 7 days.